Four-Week Daily Calcipotriene/Betamethasone Dipropionate Foam Is Highly Efficacious in Patients With Psoriasis (PSO-LONG Lead-in Phase)

April 2021 | Volume 20 | Issue 4 | Original Article | 436 | Copyright © April 2021


Published online March 31, 2021

Richard B. Warren PhDa, Michael Gold MDb, Melinda Gooderham MDc, Leon H. Kircik MDd, Jean-Philippe Lacour MDe, Philip Laws MBChBf, Monika Liljedahl MDg, Charles Lynde MDh,i, Marie Holst Mørch MSg, Wiebke Sondermann MDj, Diamant Thaçi MDk

aDermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, UK
bTennessee Clinical Research Center, Nashville, TN
cSkin Centre for Dermatology, Peterborough, Ontario, Canada; Probity Medical Research, Waterloo, ON, Canada; Queen’s University, Kingston, ON, Canada
dDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY
eDepartment of Dermatology, University Hospital of Nice, University of Nice Côte d’Azur, Nice, France
fDepartment of Dermatology, Leeds Teaching Hospitals, Leeds, UK
gLEO Pharma, Ballerup, Denmark
hLynde Dermatology, Probity Medical Research, Markham, ON, Canada
iDepartment of Medicine, University of Toronto, Toronto, ON, Canada
jDepartment of Dermatology, Venereology and Allergology, University Hospital Essen, University Duisburg-Essen, Essen, Germany
kInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany

Abstract
Background: Psoriasis is a chronic disease requiring long-term treatment strategies. Optimal strategies should include initial rapid relief of symptoms followed by long-term management to maintain remission. This 4-week open-label phase of a long-term proactive management phase 3 trial aimed to select responders to once daily, fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% (Cal/BD) foam in adults with psoriasis and assess patient-reported outcomes.
Method: This phase 3 trial in adults with psoriasis included a 4-week open-label lead-in phase to determine treatment success prior to entering the randomized maintenance phase. Success was defined as Physician Global Assessment (PGA) score ‘clear’/‘almost clear’ (PGA <2) with ≥2-grade improvement from baseline. Those achieving treatment success at week 4 entered the maintenance phase; non-responders were withdrawn from the trial.
Results: 650 patients enrolled in the open-label phase, and 623 were treated with Cal/BD foam for 4 weeks; 521 (80%) patients achieved treatment success and were included in the maintenance phase. In those patients achieving success (responders), 21.1% and 78.9% achieved a PGA score of ‘clear’ and ‘almost clear’, respectively. Mean change from baseline in modified Psoriasis Area and Severity Index (± standard deviation [SD]) and body surface area (± SD) in responders at week 4 was −82.1% (16.4%) and −56.6% (38.3%), respectively. Mean Dermatology Life Quality Index score reduced by 6.0 from baseline to week 4 (n=521). 17.7% of patients experienced AEs; with only one severe AE reported.
Conclusion: Cal/BD foam was highly efficacious and well tolerated during the 4-week lead-in phase of PSO-LONG.

J Drugs Dermatol. 2021;20(4):436-441, doi:10.36849/JDD.5728

INTRODUCTION

Plaque psoriasis, or psoriasis vulgaris, is a chronic, debilitating, inflammatory disease,1,2 characterized by well-defined erythemato-squamous plaques surrounded by normal skin.2 Various treatments are available for psoriasis, including topical treatment (considered first-line treatment) for mild-to-moderate disease and phototherapy or systemic/biologic agents (considered first- or second-line treatment) for moderate-to-severe disease.1

Despite the numerous treatment options for psoriasis, maintaining long-term control remains a challenge, due to the relapsing nature of the disease, and many patients remain untreated or undertreated.3 Currently, topical psoriasis treatment relies on a reactive approach to disease relapses, as opposed to a long-term proactive management approach aimed at maintaining disease remission.4 Psoriasis is a chronic disease that requires a safe long-term treatment strategy.